Note: Descriptions are shown in the official language in which they were submitted.
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INSTRUMENT FOR INSERTING GRAFT FIXATION DEVICE
Technical Field
The field of art to which this invention relates is
surgical fastening devices, in particular, surgical
fastening devices for fixating tissue grafts to bone.
Background of the invention
The medical technology associated with tissue
engineering has advanced at a rapid pace. In particular,
it is now known to harvest cells from the human body, for
example, chondrocytes and fibrochrondrocytes from the
knee joint. These autologous cells are then cultured in
a laboratory environment on a bioabsorbable matrix. The
matrix will typically have a shape substantially similar
to the tissue section which needs to be replaced. After a
sufficient period of time in an appropriate culture
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medium at the proper environmental conditions, the
harvested cells will grow on the matrix to form an
implantable section of tissue having substantially the
same physical configuration as the section of tissue
which needs to be replaced in the patient. Such a
tissue-engineered construct, consisting of cells on the
matrix (or, alternatively, consisting of a matrix alone
without cells), is then affixed to the bone site using
conventionally known surgical fasteners including
sutures, periosteal coverings, or fibrin glue.
The advantages of tissue engineering are many, not
the least of which is, for example, that it is now
possible to replace cartilage with living cartilage
tissue. In addition, the likelihood of rejection of the
tissue implant is minimized since the cartilage tissue
which has been grown in-vitro is identical to the
autologous cartilage of the patient.
Although existing matrix fixation devices are
adequate for their intended use, there are also some
disadvantages attendant with their use. First of all
these fixation devices are generic in the sense that they
are not specifically designed for matrix fixation to bone
or soft tissue, but can be used for a variety of surgical
procedures. Other disadvantages include the difficulty
in using many of these devices in a minimally invasive
arthroscopic procedure. Additional disadvantages include
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the difficulty and surgical challenge of harvesting a
piece of periosteum for use as a periosteal flap, the
significant patient morbidity associated with such
harvesting, and the difficulty in suturing such a thin,
compliant material to surrounding tissue.
Accordingly, there is a need in this art for novel
fixation devices that will effectively affix a matrix of
tissue-engineered tissue to a bone or other anchoring
site so that the tissue may continue to grow and
regenerate in the patient's body.
Disclosure of the Iawutioa
Therefore, it is an object of the present invention
to provide a fixation device that effectively fixates a
tissue-engineered matrix to a bone or other anchoring
site, thereby enabling the implanted matrix to remain in
place while the tissue continues to grow and regenerate.
It is a further object of the present invention to
provide such a device for fixating a matrix to a bone
site which is easily installed using an arthroscopic
procedure or an open procedure.
It is yet a further object of the present invention
to provide such a device for fixating a matrix to a bone
site which does not require sutures or suture knot tying.
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It is still yet a further object of the present
invention to provide a surgical method for fixating a
matrix utilizing such a device in a location within a
patient's body.
Accordingly, a graft fixation device is disclosed.
The graft fixation device has first and second
implantation members. The members are elongated and
preferably have a cylindrical configuration. The members
also have distal ends, proximal ends, and longitudinal
axes. There are longitudinal passages extending through
the e4tire length of each implantation member. The
members have outer surfaces. The implantation members
are connected to each other by a rod member having first
and second ends and a central section. The first end of
the rod member extends from the proximal end of the first
implantation member and the second end of the rod member
extends from the proximal end of the second implantation
member. The rod member is preferably relatively rigid
and may be configured to have a variety of geometric
shapes, for example, an inverted "U" shape. However, the
rod member may also be flexible. The rod member maintains
the implantation members at a relatively fixed distance
from each other. The central section of the rod member
is designed to engage a section of a tissue-engineered
matrix implant. In a preferred embodiment, the
implantation members have a series of ridges extending
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= out from the outer surfaces of the implantation members
to assist in preventing withdrawal from a bone site or
other anchoring site after the implantation members are
implanted into previously-created bore holes.
Yet another aspect of the present invention is a
method of using the graft fixation device of the present
invention to affix a matrix containing tissue-engineered
tissue to a bone.
Still yet another aspect of the present invention is
a graft fixation device combination which is the
combination of a fixation device and an insertion member.
The fixation device has a first implantation member. The
implantation member has a longitudinal axis, a proximal
end, a distal end, an outer surface, and a longitudinal
passage therethrough. The fixation device also has a
second implantation member. The second implantation
member has a longitudinal axis, a proximal end, a distal
end, an outer surface, and a longitudinal passage
therethrough. Each implantation member has a proximal
annular face on its proximal end surrounding the
longitudinal passages. There is a connecting member
connecting the first and second implantation members.
The connecting member has a central section, a first end
extending from the first implantation member and a second
end extending from the second implantation member.
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There are a pair of insertion devices. Each insertion
device is a member having a proximal end, a distal
tapered end and a longitudinal passage therethrough. The
distal end of each implantation member is in engagement
with the proximal end of an insertion device.
Yet another aspect of the present invention is an
insertion instrument for inserting the fixation devices
and combinations of the present invention in bone. The
instrument has a removable distal end housing and
removable prongs. The instrument has an elongated member
having a proximal end, a distal end, a distal end
surface, and an outer surface. Outer screw threads
extend out from the outer surface about the distal end.
There is a hollow member having a cavity, a proximal end
and a distal end, and an outer surface and an inner
surface, said hollow member having an opening in the
proximal end in communication with the hollow cavity.
Inner screw threads extend out from the inner surface of
the hollow member. A pair of spaced apart prong holes
extend through the distal end of the hollow member, said
prong-holes being in communication with the cavity. A
retention groove extends into the inner surface of the
distal end of the hollow member There are a pair of
prongs, said prongs having elongated members having
distal ends and proximal ends. In a preferred
embodiment, a piercing point extending distally from the
distal end of each prong. A retention member is mounted
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to the proximal end of each prong, and the retention
member has a proximal surface. The instrument is
assembled by inserting the prongs through the prong
holes, such that the prongs extend through the prong
holes, and the proximal retention members are contained
within the retention groove. The hollow member is then
screwed onto the distal end of the elongated member, by
engaging the mating inner threads with the outer threads,
and rotating the hollow member until the distal end
surface of the elongated member is in engagement with the
proximal surfaces of the retention members.
$till yet another aspect of the present invention is
the combination of the insertion instrument as described
above and a graft fixation device and combination of the
present invention.
A further aspect of the present invention is
an instrument for inserting a graft fixation device into
bone. The instrument has a mounting member having a
first end, an opposed second end, a top and a bottom.
There is an elongated slide rod having a proximal
end and a distal end and an outer surface and a
longitudinal axis. The distal end of the slide rod is
mounted to the first end of the mounting member such that
the longitudinal axis of the slide rod is angulated at
an acute angle with respect to the mounting member.
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A hammer handle member is slidably mounted to the slide
rod. The hammer handle has a distal end, a proximal end,
an outer surface, a first flange member extending from
the proximal end, a second flange member extending from
the distal end, an inner passage therethrough and a
longitudinal axis. There is a mounting rod having a
proximal end and an angulated distal end. The angulated
distal end has a longitudinal axis and the proximal end
of the mounting rod is mounted to the second end of the
mounting member. A pair of spaced apart prongs extends
longitudinally from the distal end of the mounting rod.
The longitudinal axis of the slide rod is parallel to the
longitudinal axis of the angulated distal end of the
mounting rod.
Another aspect of the present invention is a method
of using the above-described surgical instrument to
perform a surgical procedure.
These and other features and advantages of the
present invention will become more apparent from the
following description and accompanying drawings.
Briof Description of the Drawings
FIG. 1 is a perspective view of a graft fixation
device of the present invention.
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FIG. 2 is a cross-sectional view of the graft
fixation device of FIG. 1 taken along view line 2-2.
FIGS. 3-6 illustrate a surgical procedure for
affixing a matrix to bone using the graft fixation device
of the present invention.
FIG. 7 is an illustration of a graft fixation device
of the present invention after the implantation members
have been implanted in bore holes in bone illustrating
the device affixing a matrix securely to the surface of a
bone.
FIG. 8 is a cross-sectional view of the graft
fixation device of FIG. 7 implanted in bone, and taken
along view Line 8-8.
FIG. 9 is an alternative embodiment of a graft
fixation device of the present invention having two
connecting members.
FIG. 10 is a perspective view of an instrument
useful for making bore holes in bone into which the
implantable members of the graft fixation devices of the
present invention may be emplaced.
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FIG. 11 is a perspective view of an instrument
useful for implanting the device of the present invention
into bore holes made in bone.
FIG. 12 is a view of a tissue engineered matrix
secured to a bone with several graft fixation devices of
the present invention.
FIG. 13 is a perspective view of an alternate
embodiment of a graft fixation device of the present
invention.
FIG. 14 is a side view of the graft fixation device
of FIG. 13.
FIG. 15 is an end view of the graft fixation device
of FIG. 14.
FIG. 16 is a cross-sectional view of the graft
fixation device of FIG. 14, taken along View-Line 16-16.
FIG. 17 is a cross-sectional view of the tissue
retention member of the graft fixation device of FIG. 14,
taken along View-Line 17-17.
FIG. 18 is a perspective view of an insertion member
useful to insert a graft fixation member of the present
invention.
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FIG. 19 is an exploded perspective view of an
insertion instrument, a graft fixation device, and two
insertion members.
FIG. 20 is a side view of the distal end of the
insertion instrument, a graft fixation device, and
insertion members engaged in bone, prior to removal of
the insertion device.
FIG. 21 is a cross-sectional view taken along View-
Line 21-21 of FIG. 20 of the prong of the insertion
instri4nent, and a section of the retention member engaged
in a longitudinal groove of the prong.
FIG. 22 is an exploded perspective view of the
distal end of an insertion instrument of the present
invention, illustrating a removable distal end assembly
for creating bore holes in bone for receiving the
fixation devices of the present invention, wherein the
assembly has-an end member and pins.
FIG. 23 is a cross-section of the assembly end
member of FIG. 22, taken along View-Line 23.
FIG. 24 is a perspective view of the assembly end of
FIG. 22, completely assembled and ready for use.
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FIG. 25 is a cross-sectional view of the end
assembly of FIG. 24, taken along View-Line 25-25.
FIG. 26 is an exploded perspective view of an
insertion instrument of the present invention having a
removable distal end assembly useful for inserting the
graft retention members of the present invention into
bore holes in a bone, having an end assembly member and
two pins; when used with insertion members, the
instrument can be used to emplace the fixation devices
directly into bone without first forming bone bore holes.
FIG. 27 is a cross-sectional view of the end
assembly member of FIG. 26.
FIG. 28 is a perspective view of the distal end of
the insertion instrument of FIG. 26, having the end
assembly member and prongs fully assembled and mounted.
FIG. 29 is a cross-sectional view of the distal end
of the insertion instrument of FIG. 28 take along View-
Line 29-29.
FIG. 30 is a cross-sectional view of the instrument
of FIG. 29 taken along View-Line 30-30.
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FIG. 31 illustrates a fixation device of the present
member having an insertion member molded into the distal
end of each implantation member.
FIG. 32 is a cross-sectional view of the fixation
device of FIG 31.
FIG. 33 is a perspective view of a novel combination
slap-hammer and insertion instrument useful to insert the
fixation devices of the present invention.
FIG. 34 is a side view of the instrument of FIG. 33.
FIG. 35 is a front view of the instrument of FIG.
34.
FIG. 36 illustrates a side view of the instrument of
FIG. 33 shown engaging the bottom surface of femur.
FIG. 37 is a side view illustrating a conventional
slap hammer instrument engaging the bottom surface of a
femur.
Description of the Preferred mabodimeats
~ . ..~..
The graft fixation devices of the present invention
can be made from conventional bio-compatible materials,
including absorbable and non-absorbable materials, as
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well as biodegradable materials. The non-absorbable
materials which can be utilized include conventional
biocompatible materials such as stainless steel,
polyethylene, Teflon, Nitinol, non-absorbable polymers,
other bio-compatible metals, ceramics, combinations
thereof and the like. The absorbable materials which can
be used to manufacture the graft fixation devices of the
present invention will typically include those
conventional bioabsorbable or bioresorbable materials
known in this art which can be effectively molded or
machined. The bio-absorbable and bio-resorbable
materials include polylactic acid, polydioxanone,
polycaprolactone, polyglycolic acid, polygalactic acid,
other known biocompatible bioabsorbable and bioresorbable
polymers, ceramics, composites, combinations thereof and
the like and equivalents thereof.
Referring now to FIGS. 1-2, a preferred embodiment
of a graft fixation device 10 of the present invention is
illustrated. The graft fixation device 10 is seen to
have implantation members 20. The implantation members
20 are seen to be elongated members, preferably having a
substantially cylindrical shape. The members 20 may have
other geometric shapes including conical, pyramidal,
polygonal, cubic, spherical, etc. The implantation
members 20 Oare seen to have distal ends 22 and proximal
ends 24. Each implantation member 20 is seen to have an
outer surface 28 and a longitudinal axis 29. Each member
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20 is also seen to have longitudinal passage 35 extending
therethrough. The implantation members 20 are also seen
to have optional frustoconical ends 30, and proximal
endface surfaces 32. Although it is preferred that
endface surfaces 32 be flat, endface surface 32 may also
be angled, concave, convex, etc. Endface surface 32 is
seen to have central circular opening 36 in communication
with passage 35. Preferably, central opening 36 will have
a circular cross-section, but it may have other geometric
cross-sections as well including elliptical, polygonal,
square, rectangular, combinations thereof and the like.
Members 20 are also seen to have distal end face surfaces
37 having circular openings 38 in communication with
passages 35. As shown with the optional frustoconical end
30, the annular end face surface 37 is of de minimis
thickness around opening 38, however this thickness would
increase in the absence of a frustoconical end. Also
seen to extend out from the surface 28 of member 20 are a
series of optional projections 40 having tissue
engagement edges 44. Without the projections 40, the
surface 28 of the member 20 will be smooth.
The device 10 is seen to have graft retention member
50 connecting the implantation members 20. Retention
member 50 is seen to be a rod-like member having first
end 52, second end 54 and central section 55. First end
52 is seen to extend from proximal endface surface 32 of
the first member 20 while end 54 is seen to extend up
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from the proximal endface surface 32 of the other member
20. The ends 54 and 52 of retention member 50 may also
if desired extend from or be mounted to any section of
outer surface 28. The connecting member 50 is seen to be
preferably bent or shaped into three segments including
top segment 55 and leg segments 56. The top segment 55
is seen to be substantially perpendicular to the leg
segments 56. Although it is preferre d that connecting
member 50 have an inverted "U" configuration, the
connecting member 50 may have other geometric
configurations including semicircular, arced, curved,
triangular, polygonal, U-shaped, and the like and
combir~ations thereof. The ends 52 and 54 of connecting
member 50 may be permanently affixed to the implantation
members 20, or may be removably attached thereto in a
conventional manner. Member 50 may be rigid or flexible.
Member 50 will have a sufficient surface area to
effectively retain a tissue-engineered matrix in place on
a bone or other body surface. Preferably, connecting
member 50 will have a circular cross-section, but may
have other geometric cross-sections as well including
elliptical, polygonal, square, rectangular, combinations
thereof and the like. Member 50 may be rigid or
flexible, and may have a single filamentary structure or
have multiple interconnected filaments or members.
Referring now to FIGS. 3-8, the use of the graft
fixation devices 10 of the present invention in a
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surgical procedure is illustrated. Referring first to
FIG. 3, the initial step, prior to the installation of a
matrix containing a tissue-engineered tissue using a
graft fixation device 10 of the present invention, is to
drill or "tap" two bore holes 200 into a bone 210, for
example, subchondral bone in the knee joint. The bore
holes 200 are seen to be cylindrical holes having a
bottom 208 and an open top 202 and side walls 205.
Optionally, the bore holes may be bone tunnels with a
continuous passage and no bottom, or an open bottom. It
is particularly preferred to tap the holes in the bone by
using an instrument 400 as illustrated in FIG. 10 which
has a,proximal section conventionally referred to in this
art as a"slap hammer" section. The term "tapping" or
"tap" as used herein is defined to mean a procedure
wherein the distal pointed prongs 420 extending from the
distal end 415 of the shaft 405 of instrument 400 are
located over a bone site, and-the proximal end 410 of
instrument 400 is tapped or hit with slidable hammer
handle 450 (of the "slap hamaner"), which slides on shaft
460 between proximal end 410 and proximal stop 470, to
form the bone bore holes 200. The distal end 465 of
shaft 460 is connected to proximal end 411. Proximal
stop 470 is mounted to proximal end 467. Hammer handle
450 is seen to have grasping section 451, collars 455 and
longitudinal passage 457. Those skilled in the art will
appreciate that a similar pointed instrument may be used
to "tap" in the bore holes into bone, that is, any
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instrument having a nail-like distal end. In addition,
although not preferred, one bone bore hole at a time may
be "tapped" in. If the surgeon decides to drill the bore
holes into bone, any conventional surgical drilling
apparatus may be used. After the bore holes 200 are
formed into the bone 210, the matrix 220 containing
tissue-engineering tissue is placed upon the bone surface
201 by the surgeon as seen in FIG. 4. Next, the graft
fixation device 10 is mounted on to the insertion
instrument 250. Insertion instrument 250, as illustrated
in FIG. 11, is seen to be an elongated rod 260 having a
proximal end 262 and a distal end 264. Mounted to the
distal end 264 of the rod 260 is the depth stop 290. The
depth stop 290 is seen to be a substantially rectangular
member which is mounted perpendicular to the longitudinal
axis 251 of the rod 260. Depth stop 290 is seen to have
bottom 292. Extending distally from the bottom 292 of
plate member 290 is a pair of parallel, spaced-apart,
mounting prongs 270. The mounting prongs 270 are seen to
be substantially rod-like members having distal pointed
tips 277 and proximal ends 272. The prongs 270 are seen
to have first section 273 and distal section 275.
Section 273 is seen to have a greater cross-sectional
dimension than distal section 275 such that the entire
section 275 is insertable into passages 35 of members 20,
while proximal section 273 is not insertable therein.
Instrument 250 is also seen to have a "slap hammer
section" consisting of proximal shaft 300 extending from
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proximal end 262, slidable hammer handle 320 (the "slap
hammer") which is slidable upon shaft 300 between
proximal end 262, and proximal stop 330. Hammer handle
member 320 is seen to have grasping section 325, end
collars 327 and longitudinal passage 329. The graft
fixation device 10 is mounted to the insertion instrument
250 by sliding the implantation members 20 onto the
prongs 270 such that the distal sections 275 of members
270 are engaged within the longitudinal passages 35 of
members 20 and distal points 277 protrude beyond the end
of distal endface surfaces 37. Then, as seen in
FIGS. 5 and 6, the instrument 250 is manipulated such
that the graft fixation device 10 is inserted through
matrix 220 and into bone 210 by moving the implantation
members 20 mounted on prongs 270 into the bore holes 200
such that the members 20 are engaged in the bore holes
200, and such that the tissue engagement section 55 of
the retention member 50 engages the matrix 220 such that
the matrix 220 is firmly engaged against the surface 201
of the bone 210. If desired, holes may be cut into
matrix 220 prior to insertion of device 10. Then, as
seen in FIG. 7, the insertion instrument 250 is withdrawn
proximally causing the prongs 270 to be withdrawn from
the passages 35 of the implantation members 20, thereby
leaving the graft fixation device 10 engaged in the bone
bore holes, and causing the matrix 220 to be maintained
in engagement with the surface 201 of bone 210. The "slap
hammer" section of instrument 250 may assist in removal
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of the prongs. A cross-sectional view illustrating the
device 10 engaged in bone 210 while maintaining the
matrix 220 on bone surface 201 is seen in FIG. B.
FIG. 12 illustrates a matrix 220 mounted to bone
surface 201 of bone 210 having multiple fixation devices
of the present invention installed to secure the matrix
220. The number, anatomical location and orientation of
fixation devices 10 necessary to provide sufficiently
effective fixation will vary with the size and type of
implant or matrix, the type of tissue, the age of the
patient, the size of the patient's defect, the size of
the fi,xation devices, the material of construction of the
fixation devices, the load on the tissue at the repair
site, etc.
Those skilled in the art will appreciate that the
size of the fixation devices of the present invention
will vary in accordance with a number of variables
including the specific design of the device, the
materials of construction, the specific application for
the devices, the type of surgical procedure, etc.
Similarly, the size of the matrices fixated with these
devices will similarly vary. The Figures which are part
of this specification are merely schematic and
illustrative of the device and method of the present
invention; the actual dimensions of the devices and
matrices may vary in practice.
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The following example is illustrative of the
principles and practice of the present invention although
not limited thereto.
87CAMPLE
Six sheep were prepared for a surgical procedure
using standard aseptic surgical techniques including the
use of fully sterilized instruments and equipment, and
conventional anesthesia procedures and protocols. The
surgeon then created 7mm diameter chondral (full
thick4ess cartilage) defects on a weight-bearing area of
the medial femoral condyle and in the trochlear groove in
the right stifle (knee) in each of the six skeletally
mature sheep. Defects were created using a specialized
drill with a depth-stop to prevent subchondral bone
exposure or penetration. The base surfaces of all the
defects were then microfractured with a specialized
micropick tool to provide access for cellular migration.
The subjects=were then separated into three groups of two
subjects each:
Group 1: defect filled with a collagen matrix,
fixed with the graft fixation device of the present
invention.
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Group 2: defect filled with a collagen matrix,
fixed with 9-0 absorbable Vicryl?" suture
(interrupted stitch technique, approximately 12
strands per matrix)-
Group 3: unfilled defect (control group).
Both defects in a given stifle received the same
treatment or served as controls.
For the two sheep in Group 1, after a defect had
been created and microfractured, a punch tool 400 was
used to create the two requisite bore holes in the
subchondral bone to receive one graft fixation device of
the present invention. Only one polydioxanone device
(4mm tip-to-tip distance) was used to attach each matrix.
To create the bore holes, the punch tool was centered in
the defect, oriented in the sagittal plane, and hit or
"tapped" with a slap hammner repeatedly until i-t
penetrated several millimeters into the subchondral bone.
Next, a?mm diameter circular collagen matrix, saturated
with saline, was placed in the defect and then blotted
dry to remove excess saline. When the inserter tool 250
was loaded with the graft fixation device 10 of the
present invention, the device and inserter tool were
centered above the matrix and oriented in the sagittal
plane. The surgeon then located the previously created
bore holes-by slowly advancing the distal tips of the
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inserter through the matrix. Once the surgeon located
the holes with the inserter tips, a hammer was used to
fully advance the inserter tool (and implantation members
20 of the fixation device 10) through the matrix and into
the subchondral bone. The inserter tool had a depth stop
to prevent the implantation members 20 from being
inserted too deeply, thereby assuring the proper
placement of the implantation members through the matrix.
The insertion was completed when the connecting retention
member between the two implantation members initially
started to compress the collagen matrix, thereby
indicating secure fixation with the underlying
subchqndral bone. After the two defects in a given
stifle had each been repaired with a matrix and fixation
device, the stifle was closed and the sheep was allowed
to recover. It was noted by the surgeon that it took
approximately one minute to attach a matrix with a
fixation device of the present invention (Group 1),
versus approximately 15 minutes to attach a matrix with
suture alone and the requisite suture manipulation and
knot tying (Group 2).
Two weeks after the surgeries were completed, the
knee joints were surgically opened for examination.
Gross macroscopic assessment of the joints demonstrated
that all four matrices held by the graft fixation device
of the present invention were fully intact. However, all
four matrices held by sutures alone were only partially
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intact with, on average, approximately 30% of the sutures
broken on any given matrix.
Another embodiment of the fixation device of the
present invention having multiple retention members is
seen in FIG. 9. The device 300 is seen to have a pair
of implantation members 310. The implantation members
310 are substantially cylindrical members having
longitudinal axis 311, distal ends 314 and proximal ends
312. Each implantation member 310 is seen to have a
longitudinal passage 320. The members 310 are seen to
have a distal frustoconical end 330, outer surface 350,
and ridges 355 extending outward from surface 350. The
members 310 are seen to be connected by a pair of
retention members 340, having first and second ends 342
and 344 respectively.
Yet another embodiment of a fixation device of the
present invention is illustrated in FIGS. 13-17. The
graft fixation device 500 is seen to have implantation
members 520. The implantation members 520 are seen to be
elongated members, preferably having a substantially
cylindrical shape. The members 520 may have other
geometric shapes including conical, pyramidal, polygonal,
cubic, spherical, etc. The implantation members 520 are
seen to have distal ends 522 and proximal ends 524. Each
implantation member 520 is seen to have an outer surface
528 and a longitudinal axis 529. Each member 520 is also
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seen to have longitudinal passage 535 extending
therethrough. The implantation members 520 are also seen
to have optional frustoconical ends 530, and proximal end
face surfaces 532. Although it is preferred that endface
surfaces 532 be flat, endface surfaces 532 may also be
angled, concave, convex, etc. Each endface surface 532
is seen to have central circular opening 536 in
communication with passage 535. Preferably, central
opening 536 will have a circular cross-section, but it
may have other geometric cross-sections as well including
elliptical, polygonal, square, rectangular, combinations
thereof and the like. Members 520 are also seen to have
distal, end face surfaces 537 having circular openings 538
in communication with passages 535. Preferably, endface
surfaces 537 have a sharp edge configuration, but may
also have various widths with a rounded or flat
configuration. As shown with the optional frustoconical
end 530, the annular end face surface 537 is of de
minimis thickness around opening 538, however this
thickness would typically increase in the absence of a
frustoconical end. However, although not preferred, even
with a frustoconical, the end surface 537 could have
various widths as previously mentioned. Also seen to
extend out from the surface 528 of member 520 are a
series of optional projections 540 having tissue
engagement edges 544. Without the projections 540, the
surface 528 of the member 520 will be smooth, however, it
will be appreciated that surface 528 could be rough, or
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could have a variety of conventional projections such as
cones, hemispheres, rods, hooks, etc., and the like and
equivalents thereof.
The device 500 is seen to have graft retention
member 550 connecting the implantation members 520.
Retention member 550 is seen to be a band-like member
preferably having an oval cross-section. The retention
member 550 is seen to have first end 552, second end 554
and central section 555. First end 552 is seen to extend
up from proximal endface surface 532 of the first member
520 while end 554 is seen to extend up from the proximal
endface surface 532 of the other member 520. A section
557 of end 552 is seen to extend_out from section 539 of
surface 528, while section 558 of second end 554 is also
seen to extend out from a section 539 of surface 528.
The ends 554 and 552 of retention member.550 may if
desired extend from or be mounted to any section of outer
surface 528. The connecting member 550 is seen to be
preferably bent or shaped into three segments including
top segment 555 and leg segments 556. The top segment
555 is seen to an arc shaped member, and the leg segments
56 are seen to be preferably perpendicular to surfaces
532. Although it is preferred that connecting member 550
have an inverted "U" configuration, the connecting member
50 may have other geometric configurations including
semicircular, arced, curved, triangular, polygonal,
V-shaped, and the like and combinations thereof. The
CA 02372734 2002-02-22
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ends 552 and 554 of connecting member 550 may be
permanently affixed to the implantation members 520, or
may be removably attached thereto in a variety of
conventional manners, for example, a ball and socket
joint, a plug joint, etc. Member 550 may be rigid or
flexible. Member 550 will have a sufficient surface area
to effectively retain a tissue-engineered matrix in place
on a bone or other body surface. Preferably, connecting
member 550 will have an oval cross-section, but may have
other geometric cross-sections as well including
circular, elliptical, polygonal, square, rectangular,
combinations thereof and the like. Member 550 may be
rigid,or flexible, and may have a single filamentary
structure or have multiple interconnected filaments or
members.
Another aspect of the present invention is a distal
insertion member (device) useful with the fixation
devices of the present invention. As seen in FIG. 18,
the insertion device 600 is seen to be a substantially
cylindrical member having proximal end 610 and distal end
620, although device 600 may have other configurations as
well. Proximal end 610 is seen to have a flat end
surface 612. Frustoconical end section 630 is seen to
extend distally from distal end 620; although device 600
may have other configurations as well. If desired,
distal end 620 can have any tapered or curved
configuration, but it is preferred that it have a
CA 02372734 2002-02-22
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frustoconical end section extending therefrom. The
frustoconical end section 630 is seen to have outer
surface 632 and distal tip 640. The member 600 is also
seen to have exterior surface 650. Extending through
member 600 is the longitudinal passage 660 having first
circular opening 665 in communication therewith, and
second circular opening 667 in tip 640 in communication
therewith. The insertion members 600 are used in
combination with the fixation members of the present
invention to engage the fixation member in bone
simultaneously with tapping the bore holes into bone,
thereby eliminating the need for a separate step to form
the bqre holes prior to inserting the fixation member.
Referring to FIGS. 19-21, the previously mentioned
combination of an insertion member 600 and a fixation
member 500 is illustrated. Initially, a fixation member
500 is mounted to prongs 700 extending from the distal
end 415 of the shaft 405 of instrument 400. Each prong
700 is seen to have first cylindrical section 710
extending from the distal end 415 of the shaft 405. Each
cylindrical section 710 is seen to have proximal end 711
and distal end 712, and receiving grooves 715. Extending
from the distal end 712 of each first section 710 is the
central pin section 720. Central pin section 720 is seen
to have proximal end 722 and distal end 724. Extending
distally from distal end 724 of central pin section 720
is the distal pin member 730. Distal pin member 730 is
CA 02372734 2002-02-22
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seen to have proximal end 732 and distal pointed end 734.
If desired, the insertion member 600 may be molded
into or affixed to the distal end of an implantation
member 20, thereby forming a unitary structure as seen in
FIG. 31 and FIG. 32. In addition, the insertion member
600 may be mounted to the distal end of an implantation
member 520 in a conventional manner by gluing, cementing,
mechanical fastening, friction fit, and the like and
equivalent thereof.
The combination of the insertion members 600 and
fixati,on members, such as fixation member 500 of the
present invention, are used to affix a matrix to bone in
the following manner. Initially, the implantation
members 520 of a fixation device 500 are placed upon
prongs 700 of an instrument 400 such that the leg members
556 are at least partially engaged in grooves 715 in
first section 710 (see FIG. 21), and, intermediate
sections 720 of pin members 700 are engaged in passages
535 of implantation members 520, while pin members 730
extend out from the distal ends of the implantation
members 520. Then, insertion members 600 are placed over
the pin members 730, such that the pin members 730 are
engaged in passages 660, and such that the pointed
piercing ends 734 extend beyond the distal ends 640 of
the insertion member 660. Then, the tool 400 and the
assembly consisting of fixation device 500 and insertion
CA 02372734 2002-02-22
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member 600 is placed over a tissue matrix 220 placed upon
a bone 210. The piercing points are then pressed through
matrix 220 to contact the surface 211 of bone 210. A
slap-hammer section of instrument 400 is engaged to drive
the piercing points 734, insertion members 600 and
implantation members 520 into the bone 210 as bore holes
200 are formed in the bone. The instrument 400 is then
withdrawn proximately, thereby removing the intermediate
sections 720 of prongs 700 from the implantation members
520 and the pin members 730 from the insertion members
600, leaving the insertion members 600 and the
implantation members 520 securely in the bone (as seen in
FIG. ~0). This completes the affixation of the matrix
220 to the bone 210 using a single step, wherein the bore
holes in the bone are formed simultaneously as insertion
members 600 and fixation device 500 are emplaced in the
bone.
It is particularly preferred to use conventional
remote visualization surgical procedures when inserting
the fixation devices of the present invention. For
example, inserting a scope through a trocar cannula into
the joint or body cavity , while insufflating the body
cavity or joint.
The insertion members 600 will typically be made
from a strong, hard, bioabsorbable material such that
they can be driven into bone without fracturing or
CA 02372734 2002-02-22
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breaking. Examples of the types of materials which can
be used to make the insertion member 600 include
polylactic acid, tricalcium phosphate, calcium phosphate,
tetracalcium phosphate and hydroxyapatite, and any
copolymers, mixtures.or blends thereof. Although not
preferred, it is possible to make the insertion members
from a conventional biocompatible material which is not
bioabsorbable or biodegradable, such as titanium,
stainless steel, ceramics, Nitinol and the like and
equivalents thereof. The'insertion member 600 assists in
forming the bore holes 200 while protecting the
implantation members 520.
FIGS. 22-23 illustrate a disposable distal end
assembly 800 for an instrument 400 of the present
invention. When using the disposable assembly 800, it is
preferable that the distal end 415 of the shaft 405 of
instrument 400 have screw threads 418, although other
conventional detachable mounts may be used, for example a
bayonet-type mount, locking levers and tabs, male and
female mating sections, etc. As seen in FIGS. 22-25, the
assembly 800 consists of housing 810 having proximal end
811 and distal end 817. Housing 810 is seen to have
hollow cavity 815 therein. Cavity 815 is seen to be in
communication with proximal end opening 812 and distal
end openings 820. Member 810 is seen to have outer
surface 822. Outer surface 822 is preferably knurled to
facilitate the grasping and turning of the housing 810.
CA 02372734 2002-02-22
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Housing 810 is further seen to have distal end surface
825. The outer surface 822 is seen to have a tapered
section 823 which tapers toward end face 825. Contained
within cavity 815, on inner surface 818 are the screw
threads 819. Assembly 800 is also seen to have driving
pin members 830. Each driving pin member 830 is seen to
have proximal disk member 832 mounted to proximal end
831, shaft section 834 and distal pointed end 838.
Surrounding each opening 820 on the interior of the
member 810 are the annular recesses 840. The assembly
800 is mounted to the distal end 415 of the instrument
400 in the following manner. The pins 830 are inserted
into cavity 815 and through openings 820 such that the
shafts 834 and distal piercing points 838 extend through
end face 825, and the disk members 832 are contained
within the annular recesses 840. Then, the housing 810
is mounted upon the threads of distal end 415 such that
threads 418 engage mating threads 819, and screwed
further such that the proximal end surfaces 833 of the
disk members 832 are in contact with the distal end face
416 of distal end 415. After use in a surgical
procedure, the assembly 800 is removed and discarded. A
new sterile assembly 800 is utilized with a cleaned and
sterilized instrument 400 for each new procedure.
Referring now to FIGS. 26-30, a disposable end
assembly 900 for mounting to an insertion instrument 250
is illustrated. The insertion member 250 is seen to have
CA 02372734 2002-02-22
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distal end 264, having endface 265 and screw threads 266.
The assembly 900 is seen to have housing 950. Housing
950 has proximal end 952 and distal end 956 and exterior
surface 954. The exterior surface 954 is seen to have
optional knurling, and distal tapered section 957
tapering into plate member 960. Extending from distal
end 956 is the plate member 960. Plate member 960 is
seen to have distal surface 962. Housing 950 is seen to
have internal cavity 955. Housing 950 is also seen to
have proximal opening 951 in communication with cavity
955 and distal openings 970 also in communication
therewith. Housing 950 is seen to have internal screw
threads 959 extending from internal surface 958. Also
contained within the interior of.housing 950 in the
distal end 956 is the recessed groove 980. Assembly 900
is mounted to the distal end 264 of instrument 250 in the
following manner. Pins 910 are inserted through cavity
950 and openings 970 such that proximal members 922 are
engaged in groove 980. Sections 920 and 930 of pins 910
extend through openings 970. Sections 920 are seen to
have grooves 925. Then, the housing 950 is screwed on to
distal end 264 such that the threads 266 engage the
mating internal threads 959 of housing 950. The housing
is tightened until the distal end surface 265 of the
distal end 264 engages the top surfaces 923 of members
922. After a surgical procedure, the assembly 900 is
removed from instrument 250 and discarded. A new sterile
CA 02372734 2002-02-22
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assembly 900 is utilized with a cleaned and sterilized
instrument 250 for each new procedure.
A novel combination slap-hammer and insertion
instrument 1000 useful to mount the fixation devices of
the present invention in bone is illustrated in FIG. 33.
As seen in FIGS. 33-36, the instrument 1000 is seen to
have a hammer handle 1010 slidably mounted to a hammer
slide rod 1040. The hammer handle 1010 is seen to have
proximal end 1012 and distal end 1014. The handle is
further seen to have curved handle surface 1015 and
proximal flange 1017 and distal flange 1019. Adjacent to
the pzoximal flange 1017 is the proximal flange surface
1022, while adjacent to the distal flange 1019 is the
distal flange surface 1020. Hamer handle 1010 is seen
to have longitudinal passage 1030. The handle 1010 is
further seen to have proximal opening 1032, distal
opening 1034, both of which communicate with the
longitudinal passage 1030. Toward the distal end 1014 of
hammer handle 1010, and extending into the longitudinal
passage 1030, is the stop shoulder 1036. The handle 1010
is slidably mounted to the hammer slide rod 1040. Slide
rod 1040 is seen to have proximal threaded end 1042 and
distal threaded end 1044. Mounted to the proximal
threaded end 1042 is the proximal knurled nut 1050. Rod
1040 is mounted at the distal threaded end 1044 to the
distal knurled coupling 1060 having internal threads
1062. The hammer slide rod 1040 is further seen to have
CA 02372734 2002-02-22
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longitudinal axis 1070. The movement of the hammer member
1010 is seen to be constrained or limited along rod 1040
when shoulder 1036 contacts nut 1050 and when distal
flange surface 1020 contacts proximal end 1061 of
coupling 1060. The instrument 1010 is further seen to
have a mounting member 1200 having first end 1210 and
second end 1220. The mounting member 1200 is seen to
have top curved side 1230 and bottom side 1240. Mounted
to the top curved side 1230 adjacent to second end 1220
is the hammer connector 1250. Hammer connector 1250 is a
cylindrical member having a threaded end 1252. Threaded
end 1252 engages screw threads 1062 in distal end 1064 of
coupli,ng member 1060 for mounting the hammer handle 1010
and the hamaner slide rod 1040 to the mounting member 1200
in an angulated manner as shown. Adjacent to end 1210 is
the mounting rod passage 1215, having proximal end 1216
which extends through mounting member 1200. Extending
transversely through end 1210 into the passage 1215 is
the transverse threaded screw opening 1217 for receiving
retaining screw 1219. Rotatably mounted in the mounting
rod passage 1215, is the mounting rod 1110. Mounting rod
1110 is seen to have proximal screw threaded end 1112 and
distal end 1120. The diameter of threaded end 1112 is
less than the diameter of the rod 1110. Distal end 1120
is seen to have the angulated section 1125. Angulated
section 1125 is seen to have longitudinal axis 1130 which
is coincident with and/or parallel to longitudinal axis
1070. The mounting rod 1110 is seen to have longitudinal
CA 02372734 2002-02-22
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axis 1111. Adjacent to distal end 1120 is the screw
threaded mounting section 1122. Disposable end assemblies
800 and 900, as previously described, may be mounted to
threaded end 1122. The rod 1110 is maintained is a fixed
angular spatial position with respect to the mounting
member 1200 by tightening set screw 1219, but is
rotatable within the passage 1215 by loosening set screw
1219. Rod 1110 is fixed in place with respect to up and
down motion with respect to member 1200 by the mounting
top nut 1119 mounted to the proximal end 1112, and by an
internal shoulder (not shown) projecting into passage
1215 just distal to proximal end 1216. As seen in FIGS.
36 and 37, the unique angulation provided by the
instrument 1000 of the present invention provides the
orthopedic surgeon with easier access with minimal
incision when either tapping holes into a femur 1250 or
inserting fixation devices as described herein. As seen
in FIG. 37, when using a conventional slap
hammer/insertion device 250 or 400, it is necessary for
the orthopedic surgeon to make a more drastic incision
and move the patella and the patella tendon more
drastically in order to access the interior surfaces on
femur 1250, thereby complicating the procedure and
possibly causing increased trauma to the patients knee.
The unique configuration of instrument 1100 provides for
these advantages. The instruments 1100 are used to
insert the fixation devices and combinations previously
described herein using the procedures as described
CA 02372734 2002-02-22
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herein. The degree of angulation of the longitudinal
axis 1130 of the angulated section 1125 and the
longitudinal axis 1070 hammer slide rod 1040 with respect
to longitudinal axis 1111 will be sufficient to provide
effective access to the interior of a knee with minimal
length incisions and minimal displacement of the parts of
the knee. For example, the angle may typically vary from
0 degrees to 50 degrees, more preferably from 20 degrees
to 30 degrees.
The fixation devices of the present invention, and
the combination of the fixation devices with insertion
members, and methods of using such devices and
combinations, of the present invention have many
advantages. The advantages include providing a fast and
routine way to fixate a matrix of tissue engineered
tissue or other tissue. The fixation devices and
combination, because they eliminate the need for suture
knot tying, can be utilized in arthroscopic surgical
procedures that require a minimum of surgical incisions
and thus greatly reduce patient morbidity. In addition,
the fixation devices and combination have been
demonstrated to provide excellent matrix fixation
without damaging the surrounding normal cartilaginous
tissue, unlike the conventional fixation of chondral
defect matrices with traditional suture that must be
passed through (and thus damage) the surrounding tissue.
The instruments of the present invention provide for a
CA 02372734 2002-02-22
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reusable section, and a distal disposable section that
can be discarded.
Although this invention has been shown and
described with respect to detailed embodiments thereof,
it will be understood by those skilled in the art that
various changes in form and detail may be made without
departing from the spirit and scope of the claimed
invention.
